Fresenius Medical Care recalls 5008X CAREsystem devices with software versions before 4.82.4 due to potential treatment stop risks. Affected units may require software updates to prevent patient treatment interruptions.
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Fresenius Medical Care is recalling 5008X CAREsystem devices with software versions older than 4.82.4 because software issues could cause treatment to stop if certain conditions are met. This affects medical devices used in patient care settings.
Software anomalies in the device could cause treatment to stop if specific conditions are met. This might lead to interruptions in patient care without warning.
Healthcare facilities using the 5008X CAREsystem with software versions prior to 4.82.4 are most at risk. Patients receiving treatment with these devices may face interruptions in care.
Check if your device has a model number M204441 and a software version older than 4.82.4. The recall covers all units with serial numbers produced before a specific software version.
Verify your device's software version; if it's older than 4.82.4, it's affected.
Reach out to Fresenius Medical Care for guidance on updating software or other remedies.
Software versions older than 4.82.4 are affected.
Check if your device has model number M204441 and a software version older than 4.82.4.
No immediate stop is required; affected devices should be checked for software updates.
We’ve drafted a message you can send Fresen:ius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-0936-2026 — Fresen:ius Medical Care Fresen:ius Medical Care Hello, I own a Fresen:ius Medical Care that is covered by recall Z-0936-2026 from Fresen:ius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
